Safety trial of tadalafil administered during labor A phase-1 clinical study (TADAFL)

未提供0 个研究点目标入组 12 人开始时间: 2021年10月8日最近更新: 2023年4月30日

试验速览

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•20 years old and under 45 years old
•It is predicted that the baby will be delivered after 37 weeks of gestation and less than 42 weeks.
•28 weeks or more and less than 41 weeks gestation
•The expected delivery date has been determined in accordance with the Obstetrics and Gynecology Practice Guidelines Obstetrics Edition
•Single fetal flow.
•A written consent has been obtained from the person mother regardingregarding participation in the test.

•Pregnant women whose delivery method is defined as cesarean section before the start of labor (previous cesarean section, post myomectomy.
•Has a history of hypersensitivity to tadalafil.
•Patients who used PDE5 inhibitors containing tadalafil during this pregnancy.
•I am taking a drug that is contraindicated in combination with the drug in the package insert of tadalafil.
•Patients undergoing renal dialysis or having severe renal dysfunction with measured or estimated creatinine clearance of less than 30 mL / min.
•Patients with severe hepatic disorder [patients with AST (GOT) or ALT (GPT) of 100 IU / L or more].
•Patients with uncontrolled arrhythmia, hypotension (blood pressure <80/40 mmHg) or uncontrolled hypertension (resting blood pressure> 170/100 mmHg).
•When fetal morphological abnormalities including multiple malformations that may be chromosomal abnormalities are observed in the foetation by fetal ultrasonography.
•Patients with retinitis pigmentosa, hemorrhagic disease, peptic ulcer, or pulmonary vein obstructive disease.
•Patients who are judged by the principal investigator or the investigator to be unsuitable for the study.

Maternal Safty

发起方

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